cream application (catalysis, s. l. madrid) in patients ... · the extracts of ectractum cepae,...
TRANSCRIPT
1
Pilot study to verify the effects of Cicatrix® cream
application (CATALYSIS, S. L. Madrid)
in patients with keloid and hypertrophic scars
Final Report
Responsible therapist: Hana Zelenková, M-D., Ph.D.
Submitted by: Hana Zelenková, M.D., Ph.D.
For: CATALYSIS, S. L. Madrid
Svidník, April 2007
2
Contents Introduction 3
Keloid and hypertrophic scars, their definition and therapy 4
Basic product information and characteristics: Cicatrix® cream 8
Study objective 8
Study type and design 8
Time schedule 8
Materials and methods 9
Results 12
Discussion 18
Conclusion 20
Bibliography 22
Keloid scars massage technique 24
Annex I 31
Annexes 1 – 5 34
Annex II – Tables 45
Annex III – Graphs 49
Annex IV – Photodocumentation 56
Annex V CD
3
Introduction
During the period from August 1st, 2006 until April 15th, 2007 a Pilot study to verify
the effects of Cicatrix® cream application (CATALYSIS, S. L. Madrid) in patients with
keloid and hypertrophic scars was carried out at the Private Department of
Dermatovenereology DOST, Svidník, Slovak Republic.
For the purposes of the study, the said preparation, namely Cicatrix® cream was
selected and delivered by the company CATALYSIS, S. L. Madrid and employed in practice.
The product has undergone molecular activation.
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Keloid and hypertrophic scars
What often plays a decisive role during the first minutes of contact with another
person is the overall appearance and the physical attributes. These attributes, unfortunately,
might be affected quite negatively by scars. For the majority of population, hypertrophic and
keloid scars seem to pose a long-tern aesthetic and mental problem. They often limit both the
professional as well as the social life of those who are affected.
The capacity of skin to repair after various types of damage induced (mechanical,
chemical, thermal, by cold or frost), including post traumatic and post surgical damage is
individual in every human being. The same type of trauma can have totally different healing
course in two individuals. Unfortunately, not all people react adequately, showing integral
healing of the traumatised skin. An unaesthetic or otherwise disturbing scar requires efficient
treatment. This treatment is required by all patients, who are, however, not at all interested in
the patophysiological processes of skin healing.
The issue of skin healing as such as well as the possibilities of skin damage
corrections ought to be thoroughly understood by every expert involved in scar management.
Connective tissue reactions called healing sometimes resulting in the formation of scar
tissue is a very complex process. Scar tissue is rich in collagen fibres, but containes little
vessels and cells. There are no hair follicles, sebaceous or perspiratory glands, as those never
repair in the process of healing. In favourable conditions a smooth transparent discreet scar is
formed, blending into the surrounding skin. The colour of new scars is reddish, sometimes
with brownish or bluish colouring. Scars mature within the course of 8 to 18 months, their
colour changing gradually, becoming whitish or adjacent-skin-like. In some cases pigments
are deposited causing darker scar coloration, and sometimes the typical depigmentation
known as the "halo effect" emerges around the scar.
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"Per primam" healing occurs in neat post-surgery wounds. In cases of prolonged
secretion phase accompanied by the formation of granulated tissue and delayed epithelisation
we speak of healing „per secundam". Yet another type of healing is seen after inflammatory
skin lesions (acne). These scars are known as hypertrophic scars, their opposite variant
being atrophic scars.
Spontaneous keloid scars emerge after uncontrolled proliferation of collagen
structures and their aetiology is unknown. Classic hypertrophic scars emerge after burn
injuries, other scars, such as radial scars we observe in irradiated patients. We could continue
naming the types of scars in which clinical differentiation is sometimes quite difficult (for
instance hypertrophic scar versus keloid). Apart from the typical localities (shoulders,
sternum, neck) spontaneous keloid scars may emerge on the whole body skin surface. An
important role is played here by racial and genetic factors, physical influences and some
serious diseases.
Therapeutic possibilities:
The most effective therapy of new hypertrophic scars and keloids includes
intralesional application of corticoids, however, connected to a certain systemic effect risk for
the patient. In Australia, the first positive results of silicone material employment were
presented in the eighties (strips, ointments), whereby there were many extensive international
studies carried out and elaborated to prove the presumed positive effects of silicone
especially in patients with burn complications (8). Surgical interventions are not used
frequently nowadays because of the risk of frequent relapses and neither is cryotherapy, as it
may cause long-term depigmentation and its effects are insignificant and disputable.
After the initial uncritical interest in laser therapy, this option is not taken advantage of
so widely nowadays, mainly due to lack of experience.
6
What shall remain part of the therapy of keloid and hypertrophic scars with
satisfactory effects are combined approaches using the combination of topical application
of preparations containing herbal extracts such Centella asiatica, and rehabilitation,
massage, pressure and occlusive therapy procedures. Best results are obtained following
topical preparation of a preparation containing (Extractum cepae, Centella asiatica) or
heparin in combination with massage, pressure and occlusive therapy procedures,
rehabilitation balneotherapy and pulverisation, or a combination of a number of the named
procedures.
Lately, many expert monothematic publications have been issued and many
congresses held regarding scar management, attended by experts in various fields of
medicine.
There are elaborate studies in literature on scar remodelling and cosmetic management
(12) at the disposal nowadays, and there are many experts in favour of using silicone sheets in
various types of scars, whereby many methods to apply those sheets have been recommended
already (2, 5, 9). The agents on the market include SIL-K (STM s.r.o.) and Topigel (Incom
Trading s.r.o.). A new generation of topically applied preparations with very promising
effects (1) includes Cica-Care (Smith+ Nephew) – an adhesive semiocclusive transparent
silicone gel applicable in the treatment itself, as well as in the prevention of hypertrophic
scars.
Laser therapy to manage scars is still used by those advocating this type of treatment
(especially in the USA) and possible combinations of techniques are being sought constantly,
which would potentiate the resulting final effect. Most popular combinations include laser
employment and the application of silicone sheets and polymer bondages named Silon-TSR.
These materials are used as temporary skin substitutes after skin resurfacing, dermabrasion or
suffered burns. The effects reported are quite manifest (13). Another representative of modern
materials - Silon-SES Elastomer has been used with great effects in the management of post-
burn hypertrophic scars lately. To treat atrophic scars, preparations containing collagen,
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including injectable filling materials are used such as Artecoll, COLLAGENPLUS, Restylan,
Matrigel, Matridex, Surgiderm, Viscontour and others.
Despite all the facts stated and the variety of methods available to treat hypertrophic
and keloid scars none of them seems to be 100% efficient, as there are more significant and
less manifest results, according to individual response of single patients. Certain methods are
contraindicated in some patients (intralesional corticoids), others are too time or money
consuming. It may happen that their final effect is minimal despite the efforts made by the
therapist (1, 12, 17, and 19).
On the other hand, the lengthy therapy of hypertrophic and keloid scars poses no
problem to most affected patients as they are usually very patient after having tried various
methods of questionable effects, but still yearning to get results. They are usually willing to
try those new methods with promising effects.
New scars react more promptly to any type of therapy, but must not be irritated by
physical means, which is something all patients must be informed of. During therapy, the
treated locality should be protected from extreme cold and especially from sun exposure.
Intensive massage also is not recommended.
Excellent effects were observed following the application of a preparation containing
the extracts of Ectractum cepae, Alantoinu and Heparin titled Contractubex® to a relatively
broad range of scars. Literature states great effects following the application of this product to
restore tissue functionality in hypertrophic burn scars (4), in cases of induratio penis plastica
and Dupuytren’s contracture (10, 16). These preparations are safe in children (4) when used to
treat scars emerging after cryotherapy (7) and are extraordinarily effective in post-surgical
scars (3, 6, 11, 14, 15) and spontaneous keloids (11, 18, 20). Good effects have been observed
following the application silicone gel labelled Dermatix, containing a high content of Heparin,
Centella asiatica, and Aloe Vera.
Due to the broad variety of scars and to the number of these defects developed by the
population it is always great to be able to welcome a new promising product that would
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bring relief to the affected patients. Cicatrix® cream, Catalysis, S. L. Madrid, seems to be
such a preparation; moreover, it has undergone the process of molecular activation which
potentiated its actions.
Product characteristics:
Cicatrix® cream is a new product by Catalysis, S.L. Madrid, employed to treat keloid
and hypertrophic scars. The active substances contained in the cream include Centella
Asiatica and Pinus Sylvestris. The said active substances and molecular activation safeguard
the efficacy of the product in adequate indications.
Study objective:
To verify the efficacy and tolerability of the preparation Cicatrix® cream, a product by
Catalysis, S.L. Madrid, in patients with keloid and hypertrophic scars and to evaluate
differences in tolerability and in the final effect in individual patients.
Study type: Prospective randomised controlled study of type IV; with post-registration monitoring
and continuous inclusion of patients into the study according to set criteria and age.
Study design: 30 patients aged from 1 to 65 years of various sex and defect extent instructed in the
topical application of Cicatrix® cream, CATALYSIS, S. L. Madrid to localities with
hypertrophic and keloid scars.
Time schedule: June 2006 – December 2006: patient inclusion and exclusion
August 1st, 2006 - March 30th, 2007: study performance
April 2007: study results assessment and processing
May 2007: handing over of a complete results assessment
May - December 2007: presentation and publication of results
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Materials and methods The clinic carrying out the study agreed that they would elaborate the documentation,
take pictures, and inform the ordering party about any conditions in connection with the
performance of the study.
The clinic worked with and according to the following basic set of documents:
• Basic working protocol (Annex 1)
• Inclusion and exclusion criteria (Annex 2)
• Working and assessment table (Annex 3)
• Total number of patients (Annex 4)
• Patient consent form (Annex 5)
Clinic: DOST Svidník
Study duration: 8 months, from August, 1st 2006 to March 31st, 2007
*Group of patients: 30 patients (9 male, 21 female)
*Average age: 35.55 years (24.5 years of age in women, 46.6 years in men)
The youngest patient is a male aged 10 months.
Diagnosis: keloid and hypertrophic scars of various extent and aetiology
*Disease duration: average duration of 2 years, with the shortest period of 2 months
Disease extent 1 x 2cm up to 10 x 15 cm on the average,
solitary as well as multiple scars
Local finding assessment: performed 4 times – at the inclusion into the group of patients
and after 2, 6 and 8 weeks
Final assessment: upon study termination
Preparation employed: Cicatrix® cream, Catalysis S.L. Madrid
Patient information: provided by the therapist.
All patients have been informed about possible adverse effects
Inclusion criteria:
• Keloid and hypertrophic scars of various extent
• Defect duration of minimum 3 months
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• Male or female sex, Caucasian
• Resistance to previous therapy
• Inpatient or outpatient status
• Age of more than 10 months
• Voluntary participation in the trial
• Written patient consent form confirmation
• One-time participation in the trial
Exclusion criteria:
Specific exclusion criteria:
• Known allergies to the tested preparation
• Disease focus infection manifestations (superinfection requiring therapy)
• Immunosuppressive therapy
• Cancer
• Malignancies
• Employment of other drug/s and /or preparation/s in therapy
General exclusion criteria:
• Alcohol and/or drug abuse
• Painkiller abuse
• Participation in another clinical trial within the past 30 days
• Simultaneous participation in any other clinical trial
• Other reasons excluding the patient from the trial
• Restricted ability of the patient to follow therapy instructions
• Other physical or mental disorders disturbing the trial plan
• Possible consent withdrawal, presumed patient unreliability
Number of applications: 2 -3 times a day until condition improvement is reached,
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Important note: it is necessary to strictly follow the recommended massage
movements and adhere to the treatment system for at least 8
weeks
* Application duration: at least 120 days
Concomitant employment of other methods: after 4 weeks the earliest
Other medication: employed in emergency cases exclusively and based solely on recommendation of other medical experts
Laboratory screening: performed 2 times – prior to therapy commencement and after
therapy termination
(the results obtained are not subject of this study and therefore
irrelevant)
Documentation: work protocol
Photodocumentation: pictures taken during regular check-ups
Recommended daily hygiene: non irritating preparations having no influence on study
course
Therapy effect assessment:
(1- healing, 2 – significant improvement,
3 – improvement, 4 – no improvement, 5 – aggravation).
Therapy assessment made by the patients:
(1- excellent, 2 – very good, 3 – good,
4 – without changes, 5 – aggravation, irritation
Comment: The differing application periods of topical Cicatrix® cream, Catalysis S.L.
Madrid were conditioned by the extent of the areas to be treated as well as the volumes of
the said preparations delivered by the company.
Note: data marked with * are to be found in Tables No. 1, Graphs No. 1, and 2
The figures in columns indicate the numbers of patients
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Results
Basic data: For gender, number of patients, age (lowest, highest), average application
duration period (in days), average disease duration period (in years), average exacerbation
period duration and number of relapses per year see Table No. 1, and Graphs No. 1 and 2.
Specialised data: For application discontinuation, hospitalization, and most effective
preparations see Table No.2 and Graphs No. 3, 4, and 5
Specific data: For efficacy and tolerability, assessments made by the therapist and the
patients, and for adverse effects see Table No. 3, and Graphs No. 6 to 11
Diagnoses: In the group of 30 patients (consisting of 9 men and 21 women), there
were keloid and hypertrophic scars of various forms and extents, from small 1x1 cm scars to
extensive burn scars affecting areas of 10 x 15 cm.
Their aetiology (spontaneous keloids, trauma, vaccination, surgical interventions, burns) was
nor relevant for the purposes of the study.
Previous therapy: 50% of patients had used a number of topical preparations
(Contractubex®, Dermatix®, Lioton® gel, silicone sheets),
balneotherapy, laser therapy, cryotherapy, intralesional corticoids
Positive family anamnesis: 2 patients (6.66%) with spontaneous keloids
Laboratory screening: 2 patients: elevated cholesterol level
4 patients: liver tests results on the verge of normal ranges,
3 patients with glycaemia on the verge of normal range
2 patients: elevated CRP levels
3 patients: elevated FW levels
Other medication: roborans, vitamins, antihistaminic agents
13
Other medication was employed in emergency cases exclusively and based solely on
recommendation of other medical experts
Other recommended physical therapy methods:
pulverization, massage – possibly starting at therapy commencement
Any other methods were employed 4 weeks following therapy termination:
Biostimulation laser II. B, microdermabrasion, intralesional corticoids, occlusion
Local finding improvement was observed already within the first 3 weeks in 30% of the
patients and continued until the termination of the application of the tested topical
preparations
Remission impossible to be assessed so far due to lack of time, however,
none of the patients showed aggravation
Therapy efficacy (see Table No. 3, Graphs No. 6, 8, 9, 10):
Assessment made by the therapist: 15 (50.00%) patients very good
11 (37.00%) patients good
3 (10.00%) patients without effect
1 (3.3%) patient did not tolerate the therapy.
Assessment made by the patients: 13 (43.00%) patients very good
12 (40.00%) patients good
3 (10%) patients without effect
2 (6.70%) patients aggravation
Therapy tolerability (see Table No. 3, Graphs No. 7, 8, 9, 10):
Assessment made by the therapist: 15 (50.00%) patients very good
11 (37.00%) patients good
3 (10.00%) patients without effect
1 (3.3%) patient did not tolerate the therapy.
Assessment made by the patients: 13 (43.00%) patients very good
12 (40.00%) patients good
3 (10%) patients without effect
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2 (6.70%) patients aggravation
Tolerability: of Cicatrix® cream, Catalysis S.L. Madrid was very good and good
Adverse effects (following the application of Cicatrix® cream, Catalysis S.L. Madrid)
(see Table No. 3, Graph No. 11):
1 patient with skin burning sensation (3.33%),
1 patient with short term skin dryness (3.33%),
5 patients with skin reddening (17.00%),
3 patiens with itching (10.00%)
None of the patients discontinued application.
Irritative dermatitis: observed in 4 patients and resolving in 10 days
Patients excluded from the group: 1 patient was excluded after 4 weeks
Hospitalised patients: none
Comment: Cicatrix® cream, Catalysis S.L. Madrid was applied in 30 patients.
The approach consisted of basic steps:
1. washing the affected skin area or scar gently, preferably with soap, liquid soap or
shower gel containing 3-8% Ichthamol
2. pulverization
3. massage
4. after a month, the condition was assessed and combined therapy and further possible
therapeutic approaches were considered.
All patients have been instructed in massage techniques and obtained instructions in
writing. Patients were shown how to apply the preparation and instructed in pulverisation. We
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consider this effect especially important, as it is not sufficient to apply the preparation
superficially, as its mere application does not lead to permanent improvement.
During previous studies (regarding the therapy of keloid and hypertrophic scars) carried
out at our clinic (16, 17, 18, 19) we have proven that the suggested system of massaging
movements, that we have developed and used in practice for more than 15 years fosters
gradual loosening of the rigid scar fibres and causes great final effects. In combination with
pulverisations using thermal water the effect is even more potentiated.
Pulverisation is a special way of treating damaged or disease affected skin (for
example in burnt patients, patients with atopic dermatitis or psoriasis) using thermal water and
fine massage. In some defects it is possible to increase the therapeutic effect by massaging the
skin with special ointments and emulsions.
Procedure: wash the affected skin area or scar gently with soap, preferably with soap
containing 3-8% Ichthamol (SANO disinfection soap or DETA Werra body wash). Dry the
skin using a soft towel and spray it with thermal water (preferably with high selenium
content), apply a thin layer of Cicatrix cream and massage the skin using recommended
massage movements.
It is possible to repeat pulverisation while performing massage so that the skin remains
moisturised. The pressure applied to skin should not be too week or too strong, actually, the
pressure piled ought to equal the pressure of a regularly firm handshake. After the massage
the focus must be wiped and a thin layer of Cicatrix ought to be applied.
All patients were instructed in the necessity to perform massage at least 2 times a day
for the minimum of 1 month and checked by the therapist, who recommended further
approach. All patients were instructed to contact the therapist should irritation occur!!
Other therapeutic methods employed combined with the studied cream application:
Occlusion (Table No. 2): 11 patients – 36.67% (5 men, 6 women).
Occlusion (plastic foil or inert bioocclusive material) was performed after evening
treatment and left on the site for approximately 8 hours. 6 patients complained of burning
sensation after 10 days. Objectively, we revealed the occurrence of erythema and the
application of occlusion was therefore discontinued. In 5 (17.00%) patients the effect was
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very good and healing acceleration was evident as the scars were flattening. In those patients
occlusion was applied until therapy termination.
Microdermabrasion (Table No. 2): 13 patients – 43.33% (4 men, 9 women)
Microdermabrasion of every focus was performed once a week using the grid
movement system repeated three times.
This combined therapy (massage, pulverisation, and microdermabrasion) seems to
have best effects. We therefore recommend this combination be used at clinics equipped with
a microdermabrasion device.
Biostimulation type II.B. laser (Table No. 2): 18 patients – 60% (6 men, 12
women). Its usage in the treatment of keloid scars has been known for years, and we applied
this laser 2 times a week with a very good effect.
We therefore presume that the combination of massaging, pulverisation and
biostimulation laser accelerates healing and influences the final aesthetic effect.
Intralesional corticoids (Table No. 2): 6 patients – 20% (2 men, 4 women). Applied
in those patients with unconvincing effects mainly in localities, in which the tested
preparation was only applied without using massage movements or pulverisation (years,
navel).
Undesired effects:
Irritative dermatitis - occurred in 4 patients (13.33%) after 10 to 12 cream application
days. It is possible those patients had not properly understood the therapy system and did not
adhere to therapy instructions. The symptoms resolved after approximately 10 days following
application discontinuation and two patients started applying the cream again after that. In
the other two patients intralesional corticoids were applied later on.
Bacterial infection: Two patients reported they had been suffering from a bacterial
infection in the course of therapy (which is a contraindication of Cicatrix® cream, Catalysis
S.L. Madrid application), and have discontinued therapy until the symptoms of bacterial
infections were treated and resolved. The observed therapy was then continued.
Most significant effects were observed in patients with new scars – in a little boy
after cleft palate operation and a boy bitten by a dog.
17
Very good effects were observed following the application of Cicatrix® cream
Catalysis S. L. Madrid in patients with atrophic scars and striae cutis distensae (also
considered atrophic scars). Patients were applying Cicatrix® cream using the recommended
massage system and pulverisation. 4 patients with acne scars and 5 patients with stretch
marks were treated. After 6 weeks of therapy the cosmetic effects were very good (see
pictures).
Cicatrix® cream was applied in 8 patients outside the studied group.
Very good effect was observed in a female patient who developed granuloma after lip
augmentation with filling materials. After the granuloma had been expelled scarring occurred.
Following 4 weeks of Cicatrix® cream application the condition was healed totally (see
pictures).
Cicatrix® cream was applied also to a patient suffering from discoid lupus
erytematosus for 20 years. Within topical therapy, the patient would use corticoids, which
resulted in skin atrophy. Moreover, their effect was not manifest anymore, with ulcerations
emerging. Following the application of Cicatrix® cream, the local finding improved after 3
weeks, the skin was smoothened and small ulcerations and erosions healed. This patient has
been using Cicatrix® cream with great effects for 3 months already (see pictures).
Cicatrix® cream Catalysis S. L. Madrid was applied also to 2 patients with superficial
grazes, in 2 patients with burns of I. and II. severity degree and 2 female patients with skin
irritation after depilation. The application of Cicatrix® cream Catalysis S. L. Madrid caused
resolution of irritation, erythema and infiltrations symptoms within 6 days.
In patients with older scars it is necessary to prolong the application period, and
combine it with other therapeutic approaches stated above.
The patients were satisfied with the therapy and the resulting aesthetic effects were
satisfactory.
Both the therapist and the patients appreciated the texture of Cicatrix® cream.
Discussion Cicatrix® cream is a new product by Catalysis, S.L. Madrid, employed to treat keloid
and hypertrophic scars. The active substances contained in the cream include Centella
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Asiatica and Pinus Sylvestris. These active substances are responsible for its efficacy under
adequate indication and application conditions. The product has undergone the process of
molecular activation.
Molecular activation is a novel unique method to improve the biological activity of
all antioxidants, vitamins, trace elements and herbal extracts. Molecular activation increases
the activity of the said molecules 20 – 100 times. The chemical composition remains
unchanged, while their bioactivity is increased.
Spanish scientists working in Madrid laboratories have been examining the activities
of antioxidants and free radicals since 1980. In every substance, more than 20 parameters and
physical and biological properties are monitored, whereby specific properties are determined
to balance out the negative effects of free radicals in organisms responsible for health
problems.
Centella asiatica has been used in medicine for many centuries; however, it was only
in the fifties of the previous century an adequate extraction of the active components was
performed successfully.
Gotu kola extract (titred extract of Centella asiatica – TECA), Madecassoside and
Asiaticoside are the most important components of the preparation, showing activity. They all
have been described many a time, including their excellent effects shown to treat venous
hypertension, vessel circulation, oedema or varicose veins. They also decrease the level of
cholesterol and demonstrate antibacterial activity.
TECA extracts can foster collagen synthesis in arterial walls and maintain their tonus.
What is really interesting is the knowledge obtained about the changes of human fibroblasts
induced by the triterpenoids of Centella asiatica. TECA testing on animals has proven their
absolute safety. Of course the advantages of its topical application have been verified and
proven by many studies and documented experiments in the field of wound healing
acceleration were performed, describing the ways to promote skin healing after
radiodermatitis therapy and the treatment of experimental wounds and scars. TECA animal
testing has also proven analgesic effects in small animals as well as the fact that some Gotu
kola components may interfere with fertility in mice.
TECA is alleged to act as an aphrodisiac – however, this has not been proven by
research so far.
19
TECA has been tested in a row of clinical trials and the presumption has been proven
that its application accelerates the healing of surgical wounds, leg ulcers of various aetiology,
parasitic skin diseases, skin diseases of pemphigous group and scars. The healing itself is not
accompanied by any damage or scarring.
TECA testing has also shown that the extract of Centella asiatica is capable of
destroying carcinogenic cell cultures; however, it will be necessary to perform many a clinical
study to prove the alleged anticancerous effect.
Madecassoside shows evident and verified anti-inflammatory effect (verified by
French medical studies) proven while monitoring the condition of patients with hepatic
lesions. TECA application was followed by significant improvement of the condition. TECA
may be applied topically or administered systemically.
It has been clearly proven that Madecassoside and Asiaticoside accelerate and
improve collagen synthesis in the process of wound healing and they also improve the quality
of collagen fibres – namely their firmness, as has been proven by experimental observations
of application in patients with scleroderma (where they were used as auxiliary preparations).
A highly positive effect was shown in wound healing acceleration. Systemic TECA
application is not recommended in children under 1 year of age, pregnant and lactating
women and in persons treated with hypoglycaemic agents (described interaction).
The employment of Madecassoside and Asiaticoside (Madecassol) is an excellent
way to prevent keloid and hypertrophic scars formation. Their application is considered as
effective as any other treatment methods including the application of external corticoid
drugs (intralesional injections) and continuous pressure bandages.
The subject of the research is the bacteriostatic action of madecassoside. However, its
action against mycobacteria has not been clearly verified yet.
TECA employment scope: Asiaticoside and Madecassoside contained in medical
products show activity in wound healing, the treatment of burns and venous insufficiency.
They demonstrate an anti-aging effect and counteract the changes caused by cellulite.
Excellent effects have been described in patients with acne, virginal problems, and fungal
infections.
Madecassoside is employed highly purified, improving significantly the repair of
epidermis for example after various types of laser treatment, peeling and minor surgical
interventions. It improves the quality of wrinkled skin and slows down the formation of
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wrinkles, shows anti-aging effect, improves the condition of post-inflammatory
hyperpigmentations, cellulite, weather-induced skin irritation or small haematoma.
Exceptionally, following topical application irritative dermatitis or rash may occur, but
resolve quickly.
Conclusion
The application of Cicatrix® cream, Catalysis S. L. Madrid can be employed within
classic conservative monotherapy or combined therapy. It is comfortable, non invasive,
painless and affordable. It is well tolerated, has practically no contraindications and may be
employed in children without any problems.
The high percentage of therapy efficacy in the group of 26 patients subjected to
this study amounting to 87% (very good a good efficacy) makes the studied preparation
new centre of attention and opens new employment possibilities.
Cicatrix® cream, Catalysis S. L. Madrid has no ambition to become the universal
treatment instrument in scar management. However, it represents a very elegant and
highly efficient therapeutic possibility that ought to be taken advantage of by all therapists.
In the group of patients we observed good therapeutic response in most patients.
Adverse effects emerged sporadically. Only one patient discontinued application and was
excluded from the studied group. The cases of irritative dermatitis that occurred in the group
have been described already in literature by other authors and are generally known.
Cicatrix® cream Catalysis S. L. Madrid, in our opinion, should be applied, due to great
effects obtained, in combination with other recommended methods to treat keloid and
hypertrophic scars – microdermabrasion, biostimulation laser or intralesional application of
corticoids. The effects of all the said methods are potentiated, healing is accelerated and
cosmetic and aesthetic effects achieved are highly satisfactory. All this has great influence on
the mental comfort of the patients.
The preparation may be applied in children without any risk. It is recommended
to treat cryotherapy-induced scars , is extraordinarily effective in post-surgery scarring and
spontaneous keloids and can be applied after laser resurfacing (however, only after the
crusting and secernation have resolved).
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We came to the conclusion that it is advisable to distribute the preparation in tubes in
the future, so that the risk of contaminating the cream with dirty fingers is eliminated.
We perceive Cicatrix® cream Catalysis S. L. Madrid as a preparation with great
future employment prospect, showing activity in influencing the final condition of keloid
and hypertrophic scars as well as other diagnoses based on the decision made by the
therapist.
In order to improve its effects as much as possible it is inevitable to apply
Cicatrix® cream in the recommended way using massage movements (as it accelerates
the deterioration of rigid scar fibres and curbs the synthesis of capillaries) combined
with pulverisation.
We do not recommend application to patients with proven skin allergy and to
perform epicutaneous testing prior to therapy commencement.
We recommend an international multicentre study be carried out.
Bibliographical reference:
1. Carney, S.A., et al.: Cica-Care gel Sheeting in the Management of Hypertrophic Scaring.
Burns,20, 1994, s.163 - 167.
2. Ettler, K.: Léčba jizev silikonovou destičkou.Čs.Derm., 72, 1997, č.5, s.188 - 189.
3. Gabler-Sandberger,E.: Successful Treatment of Contractures and Keloids with a Scar
Gel. Therapie der Gegenwart, 132, 1993, No.4, s.24 - 25.
4. Chadzynska,M., Jablonska,S.: Contractubex in the Treatment of Burn-Induced
Hypertrophic, Keloidal Scars in Childern. Dt.Derm., 37, 1989, 1288 - 1299.
22
5. Katz, B.E.: Silicone Gel Sheeting in scar Therapy. Cutis, 56, 1995, s. 65 - 67.
6. Kolektív: Retrospektívna štúdia: Terapeutické výsledky pri liečbe jaziev a keloidov
Contractubexom comp. Firemné materiály Merz + comp.,jún 1981
7. Mende, B.: Keloidbehandlung mittels Kryotherapie. Z.Hautkr., 62, 1987, 1348 - 1355.
8. Perkins, K., Davey,R.B.,Wallis,K.A.: Silicone gel:a new therapy of burn scars and
contractures.Burns,9,1983,s.201 - 204.
9. Quinn, K.J.: Silicone gel in scar treatment. Burns, 13, 1987, s.33 - 40.
10. Schwarzlose, A.: Therapie von Induratio penis plastica durch ultraschallphorese mit
Conttractubex. Inauguradissertation, 1987.
11. Stein, G.: Erfahrungen mit der Behandlung von Keloiden und hypertrophen Narben
unterschiedlicher Genese mit Contractubex comp. Therapiewoche, 35, 1985, s.1199 -
1207
12. Strmeňová, V., Fetisovová, Ž., Adamicová,K.: Remodelácia a kozmetologické
ovplyvňovanie jaziev. Slovenský LEKÁR, 7./21, 1997, č.5-6, s.64 - 65.
13. Weiss, R.A.,Weiss, M.A.: Promising Results Found with new Interpenetrating Polymer
Network. Cosmetic Dermatology, 8,1995, No.10, s. 31.
14. Weitgasser, H.: Erfahrungen mit Contractubex comp. in der Behandlung hypertropher
Narben und Keloide. Der Praktische Artz, 25, 1971, s. 965 - 968.
15. Willital, G.H., Heine, H.: Efficacy of Contractubex gel in the Treatment of fresh Scars
after Thoracic Surgery in Childern and Adolescent. Int.J.Clin.Pharm.Res.,XIV, 1994,
No. 5-6. s. 193 - 202.
16. Zilk, S., Frederik, A.: Dupuytrensche kontraktur - Möglichkeitder physikalen
Therapie. Z.Phys. Med. Baln. Klin., 15, 1986, s.21-26.
17. Zelenková, H.: Hypertrofické jazvy a keloidy. Revue Profesionálnej sestry, 5, 1998,
č.1, s.12 - 13.
18. Zelenková, H. Liečba jaziev Contractubexom. Pharma Journal,VIII, 1998, č.1, s.9 - 10.
23
19. Zelenková, H.: Naše skúsenosti s liečbou jaziev a keloidov. Recipe, 1998, V, č. 2,
s. 58 - 60.
20. Zelenková, H.: Liečba jaziev a keloidov Contractubex gelom. Lekárnik, IV, 1999,
č. 4, s. 22.